Category: arrhythmia

Cardiovascular procedures are high volume, big business in the well developed U.S, European, and Asia/Pacific markets. But much potential procedure volume has been tapped in these markets, with any appreciable growth limited to low volume, emerging procedures.

By comparison, the less-tapped “Rest of World” potential (i.e., non-U.S., non-Europe, non-Asia/Pacific) for growth is significant. Below is illustrated the 2016 size and growth to 2022 for the major cardiovascular procedures in the Rest of World.

In 2016, the cumulative worldwide volume of the most prevalent cardiac surgeries and other cardiovascular procedures (at right) is projected to approach 15.05 million surgical and transcatheter interventions. This will include:

more than 992 thousand surgical and transcatheter heart defect repairs and valve replacement or valve repair (or 6.6% of the total);

close to 931 thousand acute stroke prophylaxis and treatment procedures (contributing 6.2% of the total);

over 374 thousand abdominal and thoracic aortic aneurysm endovascular and surgical repairs (or 2.5% of the total); and

almost 254 thousand placements of temporary and permanent mechanical cardiac support devices in bridge to recovery, bridge to transplant, and destination therapy indications (accounting for about 1.7% of total procedure volume).

During the period 2016 to 2022, the total worldwide volume of covered cardiovascular procedures is forecast to expand on average by 3.7% per annum to over 18.73 million corresponding surgeries and transcatheter interventions in the year 2022. The largest absolute gains can be expected in peripheral arterial interventions (thanks to explosive expansion in utilization of drug-coated balloons in all market geographies), followed by coronary revascularization (supported by continued strong growth in Chinese and Indian PCI utilization) and endovascular venous interventions (driven by grossly underserved patient caseloads within the same Chinese and Indian market geography).

The latter (venous) indications are also expected to register the fastest (5.1%) relative procedural growth, followed by peripheral revascularization (with 4.0% average annual advances) and aortic aneurysm repair (projected to show a 3.6% average annual expansion).

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Geographically, Asian-Pacific (APAC) market geography accounts for slightly larger share of the global CVD procedure volume than the U.S. (29.5% vs 29,3% of the total), followed by the largest Western European states (with 23.9%) and ROW geographies (with 17.3%). Because of the faster growth in all covered categories of CVD procedures, the share of APAC can be expected to increase to 33.5% of the total by the year 2022, mostly at the expense of the U.S. and Western Europe.

However, in relative per capita terms, covered APAC territories (e.g., China and India) are continuing to lag far behind developed Western states in utilization rates of therapeutic CVD interventions with roughly 1.57 procedures per million of population performed in 2015 for APAC region versus about 13.4 and 12.3 CVD interventions done per million of population in the U.S. and largest Western European countries.

Proliferation of graphene applications

The nature of graphene’s structure and its resulting traits are responsible for a tremendous burst of research focused on applications.

Find cancer cells. Research at the University of Illinois at Chicago showed that interfacing brain cells on the surface of a graphene sheet allows the ability to differentiate a single hyperactive cancerous cell from a normal cell. This represents a noninvasive technique for the early detection of cancer.

Graphene sheets capture cells efficiently. In research similar to that U. Illinois, modification of the graphene sheet by mild heating enables annealing of specific targets/analytes on the sheet which then can be tested. This, too, offers noninvasive diagnostics.

Contact lens coated with graphene. While the value of the development is yet to be seen, researchers in Korea have learned that contact lenses coated with graphene are able to shield wearers’ eyes from electromagnetic radiation and dehydration.

Cheaply mass-producing graphene using soybeans. A real hurdle to graphene’s widespread use in a variety of applications is the cost to mass produce it, but Australia’s CSIRO has shown that an ambient air process to produce graphene from soybean oil, which is likely to accelerate graphenes’ development for commercial use.

Materials

Advanced materials development teams globally are spinning out new materials that have highly specialized features, with the ability to be manufactured under tight control.

3D manufacturing leads to highly complex, bio-like materials. With applications across many industries using “any material that can be crushed into nanoparticles”, University of Washington research has demonstrated the ability to 3D engineer complex structures, including for use as biological scaffolds.

Hydrogels and woven fiber fabric. Hokkaido University researchers have produced woven polyampholyte (PA) gels reinforced with glass fiber. Materials made this way have the structural and dynamic features to make them amenable for use in artificial ligaments and tendons.

Sound-shaping metamaterial. Research teams at the Universities of Sussex and Bristol have developed acoustic metamaterials capable of creating shaped sound waves, a development that will have a potentially big impact on medical imaging.

Organ-on-a-chip

In vitro testing models that more accurately reflect biological systems for drug testing and development will facilitate clinical diagnostics and clinical research.

Stem cells derived neuronal networks grown on a chip. Scientists at the University of Bern have developed an in vitro stem cell-based bioassay grown on multi-electrode arrays capable of detecting the biological activity of Clostridium botulinum neurotoxins.

Used for mimicking heart’s biomechanical properties. At Vanderbilt University, scientists have developed an organ-on-a-chip configuration that mimics the heart’s biomechanical properties. This will enable drug testing to gauge impact on heart function.

Used for offering insights on premature aging, vascular disease. Brigham and Women’s Hospital has developed organ-on-a-chip model designed to study progeria (Hutchinson-Gilford progeria syndrome), which primarily affects vascular cells, making this an affective method for the first time to simultaneously study vascular diseases and aging.

Cardiovascular surgical and interventional procedures are performed to treat conditions causing inadequate blood flow and supply of oxygen and nutrients to organs and tissues of the body. These conditions include the obstruction or deformation of arterial and venous pathways, distortion in the electrical conducting and pacing activity of the heart, and impaired pumping function of the heart muscle, or some combination of circulatory, cardiac rhythm, and myocardial disorders. Specifically, these procedures are:

Coronary artery bypass graft (CABG) surgery;

Coronary angioplasty and stenting;

Lower extremity arterial bypass surgery;

Percutaneous transluminal angioplasty (PTA) with and without bare metal and drug-eluting stenting;

Peripheral drug-coated balloon angioplasty;

Peripheral atherectomy;

Surgical and endovascular aortic aneurysm repair;

Vena cava filter placement

Endovenous ablation;

Mechanical venous thrombectomy;

Venous angioplasty and stenting;

Carotid endarterectomy;

Carotid artery stenting;

Cerebral thrombectomy;

Cerebral aneurysm and AVM surgical clipping;

Cerebral aneurysm and AVM coiling & flow diversion;

Left Atrial Appendage closure;

Heart valve repair and replacement surgery;

Transcatheter valve repair and replacement;

Congenital heart defect repair;

Percutaneous and surgical placement of temporary and permanent mechanical cardiac support devices;

Pacemaker implantation;

Implantable cardioverter defibrillator placement;

Cardiac resynchronization therapy device placement;

Standard SVT & VT ablation; and

Transcatheter AFib ablation

For 2016 to 2022, the total worldwide volume of these cardiovascular procedures is forecast to expand on average by 3.7% per year to over 18.73 million corresponding surgeries and transcatheter interventions in the year 2022. The largest absolute gains can be expected in peripheral arterial interventions (thanks to explosive expansion in utilization of drug-coated balloons in all market geographies), followed by coronary revascularization (supported by continued strong growth in Chinese and Indian PCI utilization) and endovascular venous interventions (driven by grossly underserved patient caseloads within the same Chinese and Indian market geography).

Venous indications are also expected to register the fastest (5.1%) relative procedural growth, followed by peripheral revascularization (with 4.0% average annual advances) and aortic aneurysm repair (projected to show a 3.6% average annual expansion).

Geographically, Asian-Pacific (APAC) market geography accounts for slightly larger share of the global CVD procedure volume than the U.S. (29.5% vs 29,3% of the total), followed by the largest Western European states (with 23.9%) and ROW geographies (with 17.3%). Because of the faster growth in all covered categories of CVD procedures, the share of APAC can be expected to increase to 33.5% of the total by the year 2022, mostly at the expense of the U.S. and Western Europe.

However, in relative per capita terms, covered APAC territories (e.g., China and India) are continuing to lag far behind developed Western states in utilization rates of therapeutic CVD interventions with roughly 1.57 procedures per million of population performed in 2015 for APAC region versus about 13.4 and 12.3 CVD interventions done per million of population in the U.S. and largest Western European countries.

Global Cardiovascular Proceduresreport #C500 details the current and projected surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting myocardium and vascular system.

Cardiovascular diseases (CVDs) are a variety of acute and chronic medical conditions associated with an inability of the cardiovascular system to sustain an adequate blood flow and supply of oxygen and nutrients to organs and tissues of the body. The CVD conditions may be manifested by the obstruction or deformation of arterial and venous pathways, distortion in the electrical conducting and pacing activity of the heart, and impaired pumping function of the heart muscle, or some combination of circulatory, cardiac rhythm, and myocardial disorders.

These diseases are treated via the following surgical and interventional procedures:

Coronary artery bypass graft (CABG) surgery;

Coronary angioplasty and stenting;

Lower extremity arterial bypass surgery;

Percutaneous transluminal angioplasty (PTA) with and without bare metal and drug-eluting stenting;

Peripheral drug-coated balloon angioplasty;

Peripheral atherectomy;

Surgical and endovascular aortic aneurysm repair;

Vena cava filter placement

Endovenous ablation;

Mechanical venous thrombectomy;

Venous angioplasty and stenting;

Carotid endarterectomy;

Carotid artery stenting;

Cerebral thrombectomy;

Cerebral aneurysm and AVM surgical clipping;

Cerebral aneurysm and AVM coiling & flow diversion;

Left Atrial Appendage closure;

Heart valve repair and replacement surgery;

Transcatheter valve repair and replacement;

Congenital heart defect repair;

Percutaneous and surgical placement of temporary and permanent mechanical cardiac support devices;

Pacemaker implantation;

Implantable cardioverter defibrillator placement;

Cardiac resynchronization therapy device placement;

Standard SVT & VT ablation; and

Transcatheter AFib ablation

In 2016, the cumulative worldwide volume of these procedures is projected to approach 15.05 million surgical and transcatheter interventions. This will include:

roughly 4.73 million coronary revascularization procedures via CABG and PCI (or about 31.4% of the total),

close to 4 million percutaneous and surgical peripheral artery revascularization procedures (or 26.5% of the total);

over 1.65 million CVI, DVT, and PE targeting venous interventions (representing 11.0% of the total);

more than 992 thousand surgical and transcatheter heart defect repairs and valvular interventions (or 6.6% of the total);

close to 931 thousand acute stroke prophylaxis and treatment procedures (contributing 6.2% of the total);

over 374 thousand abdominal and thoracic aortic aneurysm endovascular and surgical repairs (or 2.5% of the total); and

almost 254 thousand placements of temporary and permanent mechanical cardiac support devices in bridge to recovery, bridge to transplant, and destination therapy indications (accounting for about 1.7% of total procedure volume).

Below is illustrated the overall global growth for each of the major categories of procedures through 2022.

There is considerable variation in the growth of cardiovascular procedures globally, but most growth is coming out of Asia/Pacific. For example, within the area of venous interventions, the growth in the use of endovenous ablation for chronic venous insufficiency is markedly higher in Asia/Pacific than in other regions, though the U.S. will remain the largest volume of these procedures.

“Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022” (Report #C500), published August 2016. See description, table of contents, list of exhibits at link. Available for purchase and download from link.

over 1.65 million CVI, DVT, and PE targeting venous interventions (representing 11.0% of the total);

more than 992 thousand surgical and transcatheter heart defect repairs and valvular interventions (or 6.6% of the total);

close to 931 thousand acute stroke prophylaxis and treatment procedures (contributing 6.2% of the total);

over 374 thousand abdominal and thoracic aortic aneurysm endovascular and surgical repairs (or 2.5% of the total); and

almost 254 thousand placements of temporary and permanent mechanical cardiac support devices in bridge to recovery, bridge to transplant, and destination therapy indications (accounting for about 1.7% of total procedure volume).

Cardiac rhythm disorders, also called arrhythmias or dysrhythmias, encompass a variety of relatively common acute and chronic conditions characterized by recurrent distortions in the electrical and contractile activity of the heart, which may cause clinically significant and progressive hemodynamic deficits and cardiopulmonary impairment.

According to the available statistics from the American Heart Association (AHA) and Heart Rhythm Society, symptomatic cardiac arrhythmias effect over 10 million Americans and account for approximately 20% of all chronic conditions treated by cardiologists in the United States.

The rate and rhythm of the heart are determined by the intrinsic rhythmicity of special tissues and structures within the heart wall muscle generated by the heart’s natural electrophysiological mechanism. Normal cardiac rate and rhythm ensure continued uninterrupted blood flow an associated supply of oxygen and nutrients to the brain and other vital organs. Irregularities in the rate, rhythm, or origin of a stimulus leading to myocardial contraction can potentially interrupt normal blood circulation, causing inadequate function of important body systems, stroke or sudden cardiac arrest and death. Heart pacing disorders usually degenerate and worsen over time.

Although cardiac arrhythmias may be triggered by congenital heart defects, in which the electrical system of the heart does not develop properly, non-congenital heart disorders are believed to be the most common causes of chronic arrhythmias. The latter is particularly true for ischemic heart disease, which results in reduced blood flow and oxygen delivery to heart tissue, and heart tissue scarring typically caused by myocardial infarction. Other causes of arrhythmia include abnormal blood and tissue concentrations of certain minerals; abnormalities of the autonomic nervous system, which is involved in cardiovascular regulation; stress; and use of alcohol, caffeine, illicit drugs, and tobacco, as well as diet pills and some other medications.

Cardiac arrhythmias are generally categorized according to their impact on heart rates. Bradycardia is an abnormally slow resting heart rate, whereas tachycardia is an abnormally high resting heart rate. Bradycardias are most commonly associated with SA node disease and/or various forms of heart block.

Tachycardias are usually classified by their origination site and may be subdivided into two broad categories, specifically, supraventricular tachycardias (SVTs) and ventricular tachycardias (VTs).

With few exceptions, cardiovascular technologies no longer command big premiums (like many other medtech sectors) and mature Western markets for cardio devices have already captured most of the readily available patient caseloads. The lines between different markets (device, drugs, materials) are blurring, while surgical specialists seek to slow the caseload migration to interventionalists. The epicenter of growth in utilization of advanced cardiovascular technologies and techniques is gradually shifting to emerging Asia-Pacific markets away from the increasingly stagnant U.S. and Western European marketplace. The latter reflects the sheer size of underserved patient caseloads, availability of funding, and increasing reliance on economical domestically reproduced sophisticated endovascular devices.

“In order to be successful, manufacturers, investors, healthcare providers, advisors, and others in cardiac surgery and endovascular fields need to understand the real dynamics and asymmetrical development pattern of different cardiovascular device markets in different geographies,” says Patrick Driscoll of MedMarket Diligence. “At the root of understanding the market is accurately and realistically gauging the current and future demand for, and likely usage of, specific medical and surgical technologies and procedures.”

MedMarket Diligence has published a comprehensive resource available to manufacturers, investors, and others with interest in cardiovascular technologies. “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022,” is a worldwide competitive analysis and forecast of existing and emerging cardiovascular technologies and procedures coupled with identification and assessment of the most promising and sizable device markets.

The report offers epidemiology and mortality data for the major cardiovascular conditions along with current assessment and projected procedural dynamics (2015 to 2022) for primary market geographies (e.g., United States, Largest Western European Countries, and Major Asian States) as well as the rest of the world.

Methodology. The MedMarket Diligence procedural assessments and forecasts are based on the systematic analysis of a multiplicity of sources including (but not limited to):

Latest and historic company SEC filings, corporate presentations, and interviews with product management and marketing staffers;

Data released by authoritative international institutions (such as OECD and WHO), and national healthcare authorities;

Statistical updates and clinical practice guidelines from professional medical associations (like AHA, ACC, European Society of Cardiology, Chinese, Indian, and Japanese Societies of Cardiology, etc.);

The global market for cardiovascular devices is in the billions. Its size and association with life-saving clinical utility ensures that investors will support a surprisingly strong range of innovations in an otherwise very well-established medtech market. There is stable growth in many cardio technologies that have attained “gold standard”; aggressive growth in China, India, and Japan; and select new cardio technologies expected to rapidly seize caseload.

During the forecast period 2016 to 2022, the total worldwide volume of cardiovascular surgical and interventional procedures, tracked by MedMarket Diligence, is forecast to expand on average by 3.7% per annum to over 18.73 million corresponding surgeries and transcatheter interventions in the year 2022. The largest absolute gains can be expected in peripheral arterial interventions (thanks to explosive expansion in utilization of drug-coated balloons in all market geographies), followed by coronary revascularization (supported by continued strong growth in Chinese and Indian PCI utilization) and endovascular venous interventions (driven by grossly underserved patient caseloads within the same Chinese and Indian market geography).

The latter (venous) indications are also expected to register the fastest (5.1%) relative procedural growth, followed by peripheral revascularization (with 4.0% average annual advances) and aortic aneurysm repair (projected to show a 3.6% average annual expansion).

Geographically, Asian-Pacific (APAC) market geography accounts for slightly larger share of the global CVD procedure volume than the U.S. (29.5% vs 29,3% of the total), followed by the largest Western European states (with 23.9%) and ROW geographies (with 17.3%). Because of the faster growth in all covered categories of CVD procedures, the share of APAC can be expected to increase to 33.5% of the total by the year 2022, mostly at the expense of the U.S. and Western Europe.

However, in relative per capita terms, covered APAC territories (e.g., China and India) are continuing to lag far behind developed Western states in utilization rates of therapeutic CVD interventions with roughly 1.57 procedures per million of population performed in 2015 for APAC region versus about 13.4 and 12.3 CVD interventions done per million of population in the U.S. and largest Western European countries.

The MedMarket Diligence has published a global analysis and forecast of cardiovascular procedures, designed to be a resource for active participants or others with interest in the future of cardiovascular medicine and cardiovascular technologies.